Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care

NCT04877197 | Recruiting Phase 3 DMC

• 2 other identifiers: F3377-RRX003377-01A2
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants will receive either (1) twelve sessions of BA-HT or (2) standard best practices post CVD hospitalization care. Study participants will be 132 Veterans discharged from the Ralph H. Johnson VA Medical Center inpatient care facilities with CVD diagnoses corresponding to ICD 10 codes I20-I25 (120 unstable angina, stable angina; 121 NSTEMI, STEMI, initial encounter; 122 NSTEMI, STEMI, subsequent encounter; 124 acute coronary syndrome; 125 coronary arteriosclerosis with angina). They will be male or female, age 21 and above, and with approximately 40-50% minority representation. There will be assessment at baseline, 1 week post treatment, as well as 3 and 9-months post treatment. The investigators predict that BA-HT will more effectively increase social role and activity functioning, activity, mood and reduce 9-month re-hospitalization compared to current best-practices post-discharge care among patients scoring at least moderately depressed on the PROMIS Depression scale one week following hospital discharge for a CVD event.

Conditions

Depression; Cardiovascular Diseases

Keywords

Veterans; Mental Health; Veterans Health; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• PROMIS Ability to Participate in Social Roles and Activities

  This measure of functioning assesses one's perceived ability to perform usual social roles and activities. Items are worded negatively in terms of perceived limitations and are reverse-coded with higher scores represent fewer limitations. Each of the 8 items are scored 1 to 5 and totaled raw scores are used to derive T-scores, scaled to US general population estimates. In addition to PROMIS general validation efforts, evidence for reliability, construct validity, and sensitivity to change with cardiovascular surgery patients was provided by Flynn et al. (2015).

  13 weeks

• PROMIS Satisfaction with Participation in Social Roles

  This 8-item measure (items rated 1 to 5, higher scores corresponding to higher satisfaction), assesses satisfaction related to one's ability and performance of work, routine activities, and family activities and is responsive to change over time (Hahn et al., 2016). Thus, this measure complements purely functional assessment of capabilities with assessment of participant's impression of the quality their functioning.

  13 weeks

• PROMIS Physical Function with Mobility Aid

  This 11-item measure (high scores correspond to better mobility) is rated 1 to 5 (unable to do to "without any difficulty") and assesses self-report regarding many basic physical aspects of Activities of Daily Living. Both upper and lower extremity functioning is assessed, as well as instrumental activities.

  13 weeks

Study Arms (2)

BA-HT

EXPERIMENTAL

Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.

Behavioral: BA-HT

Standard Care

ACTIVE COMPARATOR

Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.

Other: Standard Care

Interventions

BA-HT BEHAVIORAL

Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.

Also known as: Behavioral Activation for depression delivered via home-based telehealth

BA-HT

Standard Care OTHER

Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.

Standard Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having experienced one of the ICD 10 I20-I25 CVD events:
• unstable angina
• stable angina
• NSTEMI
• STEMI
• initial encounter
• NSTEMI
• STEMI
• subsequent encounter
• acute coronary syndrome
• coronary arteriosclerosis with angina and/or
• Valve repair, valve replacement, Transcatheter Aortic Valve Implantation (TAVI/TAVR), Pacemaker Implantation in the past 6 months, Implantable Cardioverter Defibrillators (ICDs) in the past 6 months; Left Ventricular Assist Device in the past 6 months; Ablation Therapy; Watchman Implant; and
• Discharged from the RHJ VAMC inpatient care facilities
• Diagnosis of Major Depressive Disorder on the basis of the Structured Clinical Interview for DSM 5 (First, Williams, Karg, \& Spitzer, 2015)

You may not qualify if:

• Coronary Artery Bypass Grafting (CABG)
• Having a household member who is already enrolled in the study
• Active psychosis or significant dementia at screening
• Suicidal ideation with clear intent
• Current alcohol use disorder rated severe
• Concurrent enrollment in another clinical trial for depression

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Depression; Cardiovascular Diseases; Psychological Well-Being

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ron E. Acierno, PhD MS BA

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron E Acierno, PhD MS BA

CONTACT

(843) 789-7246; Ron.Acierno@va.gov

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only members of the research team who will be aware of randomization assignment will be the project therapists, the research coordinator, and the statistical analyst in charge of randomization. The outcomes assessor and investigator will be blinded to subject assignment, and though treating physicians will be informed of their patient's participation in the study, they will be blinded to treatment condition. Patients will be given instructions not to disclose their treatment assignment to their treating physicians.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will use a 2x4 (treatment by time) repeated measures RCT crossover design (baseline, post-treatment, 3 \& 9-month follow-up; crossover for standard treatment group at 9 months). At the 9 month point, the comparison group will have the option of receiving the intervention.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: January 17, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)